Description
Immune globulin and recombinant human hyaluronidase injection contains antibodies that make your immune system stronger. It is used for patients who have primary immunodeficiency (PI), including congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and other severe combined immune system problems.
Immune globulin injection belongs to a group of medicines known as immunizing agents. It is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. Hyaluronidase injection is a spreading substance that helps improve the uptake of immune globulin into the body.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of immune globulin and recombinant human hyaluronidase injection in the children younger than 2 years of age. Safety has not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of immune globulin and recombinant human hyaluronidase injection have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of immune globulin and recombinant human hyaluronidase injection in the elderly. However, elderly patients are more likely to have age-related blood clotting problems, kidney or heart problems, which may require caution for patients receiving immune globulin and recombinant human hyaluronidase injection.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin Vaccine, Live
- Benzocaine
- Bumetanide
- Bupivacaine
- Bupivacaine Liposome
- Butacaine
- Chloroprocaine
- Cholera Vaccine, Live
- Cocaine
- Dengue Tetravalent Vaccine, Live
- Dibucaine
- Ebola Zaire Vaccine, Live
- Ethacrynic Acid
- Etidocaine
- Etozolin
- Furosemide
- Influenza Virus Vaccine, Live
- Lidocaine
- Measles Virus Vaccine, Live
- Mepivacaine
- Mumps Virus Vaccine, Live
- Piretanide
- Poliovirus Vaccine, Live
- Prilocaine
- Procaine
- Proparacaine
- Propoxycaine
- Ravulizumab-cwvz
- Ropivacaine
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine, Live Non-Replicating
- Smallpox Vaccine
- Tetracaine
- Torsemide
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding problems, history of or
- Kidney problems—Use with caution. May make these conditions worse.
- Blood clotting problems, history of or
- Diabetes or
- Heart attack or stroke, recent or
- Heart or blood vessel disease or
- Hyperviscosity (thick blood), known or suspected or
- Hypovolemia (low blood volume or major loss of body fluids) or
- Paraproteinemia (paraproteins in the blood) or
- Sepsis (serious infection in the body)—Use with caution. May cause side effects to become worse.
- IgA (immunoglobulin A) deficiency with antibodies against IgA—Should not be used in patients with this condition.
Proper Use
A doctor or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach or thigh. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.
This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you are using this medicine at home, you will be shown the body areas where the medicine can be given. Use a different body area each time you give yourself an infusion. Keep track of where you give each infusion to make sure you rotate body areas. This will help prevent skin problems. Do not inject this medicine into skin with bony areas, blood vessels, scars, or areas that are inflamed or infected.
Allow the medicine to warm to room temperature for up to 60 minutes before using it. Do not warm it in any other way. Do not shake.
To use immune globulin and recombinant human hyaluronidase injection:
- Gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
- Wash your hands with soap and water before and after using this medicine.
- Check the liquid in the vials (glass container). The immune globulin solution should be clear and colorless or pale yellow. The hyaluronidase solution should be clear and colorless. Do not use it if it is cloudy, discolored, or has particles in it.
- Follow your doctor's instructions on how to prepare the correct amount of medicine.
- With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.
- Put sterile gauze and tape over the injection site to keep the needle from coming out.
- Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.
- Follow your doctor's instructions on how to use the infusion pump.
- Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.
- When all of the medicine has been infused, turn off the pump.
- Take the gauze off and remove the needle and tube from your skin.
- Clean and store the infusion pump.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (solution):
- For primary immunodeficiency:
- Adults and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 300 to 600 milligrams (mg) per kilograms (kg) at 3 to 4 week intervals, after an initial ramp-up.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For primary immunodeficiency:
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in its original container in the refrigerator for up to 36 months. You may also store it at room temperature for up to 3 months during the first 24 months from the manufacturing date printed on the carton. Do not freeze. Do not put it back in the refrigerator once kept in room temperature.
Throw away used needles and tubes in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.
While you are being treated with this medicine, do not have any immunizations (vaccines) without your doctor's approval. Do not use mumps, rubella, and varicella vaccine for up to 6 months or measles vaccine for 1 year while using this medicine.
This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin or hyaluronidase products should not use this medicine.
This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.
Check with your doctor right away if you start to have a stiff neck, drowsiness, fever, severe headache, nausea, vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).
This medicine may cause bleeding (hemolysis). Tell your doctor right away if you have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.
Check with your doctor right away if you start having red or dark brown urine, lower back or side pain, a sudden weight gain, a swollen face, arms, or legs, decreased urine output, or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.
Check with your doctor right away if you start having chest pain, difficult, fast, or noisy breathing, sometimes with wheezing, blue lips and fingernails, fever, pale skin, increased sweating, coughing that sometimes produces a pink frothy sputum, shortness of breath, or swelling of the legs and ankles after receiving this medicine. These may be symptoms of a serious lung problem.
This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jakob disease) to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Fever
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Headache
- nausea
- red streaks on the skin
- swelling, tenderness, or pain at the injection site
- unusual tiredness or weakness
- vomiting
Less common
- Itching, redness, swelling, discomfort, or pain at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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